- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05200507
High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients
6. januar 2022 opdateret af: Federico Longhini, University Magna Graecia
Physiological Effects on Lung Aeration of High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients: a Physiological Observational Study
The incidence of pulmonary complications such as pulmonary atelectasis, pneumonia (including ventilator-associated pneumonia), and acute respiratory failure is high in critical care patients.
The incidence of ventilator-associated pneumonia can be as high as 27% amongst mechanically ventilated patients.
Studies have shown that 16% of critically ill patients have been reported to develop acute respiratory failure, which is associated with prolonged intensive care unit stay, resulting in significantly higher mortality than non-respiratory failure patients.
Increased morbidity and mortality contribute to the burden on the health care system and lead to poor health-related outcomes.
Multimodal physiotherapy plays a role in the management of these critically ill patients.
High frequency percussive ventilation (HFPV) is used in patients with underlying pulmonary atelectasis, excessive airway secretions, and respiratory failure.
HFPV is a non-continuous form of high-frequency ventilation delivered by a pneumatic device that provides small bursts of sub-physiological tidal breaths at a frequency of 60-600 cycles/minute superimposed on a patient's breathing cycle.
The high-frequency breaths create shear forces causing dislodgement of the airway secretions.
Furthermore, the HFPV breath cycle has an asymmetrical flow pattern characterized by larger expiratory flow rates, which may propel the airway secretions towards the central airway.
In addition, the applied positive pressure recruits the lung units, resulting in a more homogeneous distribution of ventilation and improved gas exchange.
In acute care and critical care settings, HFPV intervention is used in a range of patients, from spontaneously breathing patients to those receiving invasive mechanical ventilation where HFPV breaths can be superimposed on a patient's breathing cycle or superimposed on breaths delivered by a mechanical ventilator.
The most common indications for HFPV use are reported as removal of excessive bronchial secretions, improving gas exchange, and recruitment of atelectatic lung segments.
This study aims to assess the lung physiological response to HFPV in terms of aeration and ventilation distribution.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Forventet)
15
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Federico Longhini, MD
- Telefonnummer: +393475395967
- E-mail: longhini.federico@gmail.com
Studiesteder
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Catanzaro, Italien
- AOU Mater Domini
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Kontakt:
- Federico Longhini, MD
- Telefonnummer: +3934753959697
- E-mail: longhini.federico@gmail.com
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
All tracheostomized patients requiring invasive mechanical ventilation for more than 48 hours and with an hypersecretive condition (as defined by need for two or more broncoaspirations per hour in the previous 8 hours) will be considered eligible.
Patients will be excluded if contro-indications to High Frequency Percussive Ventilation and/or Electrical Impedance Tomography exist.
Beskrivelse
Inclusion Criteria:
- more than 48 hours of invasive mechanical ventilation
- presence of tracheostomy
- need for two or more broncoaspirations per hour in the previous 8 hours
Exclusion Criteria:
- life threatening cardiac arrythmia
- pneumothorax
- acute spinal injury
- chest trauma
- brain injury in the previous 15 days
- hemodynamic instability
- chest or abdominal surgery in the previous 7 days
- pregnancy
- enrollment in other study protocols
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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High frequency precussive ventilation
After positioning a silicon belt for Electrical Impedance Tomography (EIT) and a baseline record, patients will receive the treatment of High Frequency Percussive Ventilation.
Further recordings will be acquired soon after the end of the treatment, 1 and 3 hours later.
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High Frequency Percussive Ventilation will be applied for 10 minutes at an oscillation frequency of 10 Hz, superimposed to the ventilatory assistance
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Lung aeration
Tidsramme: Soon after the end of HFPV application
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To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify the lung aeration (as assessed by the end-expiratory lung impedance through EIT), as compared to baseline before the treatment
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Soon after the end of HFPV application
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Lungeluftning
Tidsramme: En time efter afslutningen af HFPV-applikationen
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For at evaluere, om anvendelsen af højfrekvent perkussiv ventilation (HFPV) vil ændre lungeluftningen (som vurderet ved den endeekspiratoriske lungeimpedans gennem EIT), sammenlignet med baseline før behandlingen
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En time efter afslutningen af HFPV-applikationen
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Lungeluftning
Tidsramme: Tre timer efter afslutningen af HFPV-applikationen
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For at evaluere, om anvendelsen af højfrekvent perkussiv ventilation (HFPV) vil ændre lungeluftningen (som vurderet ved den endeekspiratoriske lungeimpedans gennem EIT), sammenlignet med baseline før behandlingen
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Tre timer efter afslutningen af HFPV-applikationen
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Arterial Blood Gases
Tidsramme: Soon after the end of HFPV application
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To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify Arterial Blood Gases, as compared to baseline before the treatment
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Soon after the end of HFPV application
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Arterial Blood Gases
Tidsramme: One hour after the end of HFPV application
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To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify Arterial Blood Gases, as compared to baseline before the treatment
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One hour after the end of HFPV application
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Arterial Blood Gases
Tidsramme: Three hours after the end of HFPV application
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To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify Arterial Blood Gases, as compared to baseline before the treatment
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Three hours after the end of HFPV application
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. februar 2022
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
31. december 2022
Datoer for studieregistrering
Først indsendt
6. januar 2022
Først indsendt, der opfyldte QC-kriterier
6. januar 2022
Først opslået (Faktiske)
20. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Percussionaire-tracheo
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
IPD-delingstidsramme
After study publication on a peer-reviewed journal in english language
IPD-delingsadgangskriterier
On reasonable request to the Principal Investigator
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
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